Cleared Traditional

K822612 - T3 UPTAKE KITS
(FDA 510(k) Clearance)

K822612 · Pcl-Ria, Inc. · Chemistry

Sep 1982

Decision

31d

Days

Class 2

Risk

K822612 is an FDA 510(k) clearance for the T3 UPTAKE KITS. This device is classified as a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ).

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 31 days after receiving the submission on August 30, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number	K822612 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 1982
Decision Date	September 30, 1982
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—